Prostate Cancer Clinical Trial
Official title:
Liposome-Encapsulated Doxorubicin (LED) in Hormone Refractory Prostate Carcinoma, Phase II
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating
patients with prostate cancer that has not responded to hormone therapy.
OBJECTIVES: I. Estimate the objective response rate of patients with hormone refractory
prostate cancer treated with doxorubicin HCl liposome. II. Determine the toxic effects
(including any cumulative cardiotoxicity) of this regimen in these patients. III. Assess the
effect of this regimen on pain and quality of life of these patients.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 45 minutes every 3 weeks.
Treatment continues in the absence of disease progression or unacceptable toxicity. Quality
of life is assessed at baseline and then every 9 weeks thereafter. Patients are followed
every 3 months.
PROJECTED ACCRUAL: Approximately 50 evaluable patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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